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Cambridge, Massachusetts, United States
Onsite
The Role
This role is an exciting opportunity to be an integral part of the talent engine fueling a high-growth organization that is radically changing the biotech industry.
Reporting to the Director, Regulatory Information Management (RIM), the Associate Director, Regulatory Data Management & Intelligence is responsible for defining and advancing Moderna’s regulatory data strategy, governance framework, and digital data ecosystem. This role serves as the Business Capability Owner for assigned Veeva Vault RIM Data capabilities, ensuring regulatory information is accurate, standardized, secure, and positioned to support evolving global regulatory requirements and Moderna’s digital transformation strategy.
The Associate Director will establish enterprise data governance, define business capabilities, and partner closely with Regulatory Affairs, Regulatory Operations, CMC, Labeling, Quality, Enterprise Data, Digital, and external technology partners to continuously improve regulatory business processes, regulatory data quality, and enterprise technology capabilities. This role balances strategic leadership with hands-on execution, serving as both a business capability owner and a trusted subject matter expert supporting Moderna’s global regulatory operations.
Serve as the Business Capability Owner for assigned Veeva Vault RIM Data capabilities, defining the strategy, governance framework, and multi-year roadmap supporting Moderna’s Regulatory Information Management organization.
Own and continuously improve regulatory master data capabilities including Applications, Registrations, Regulatory Objectives, Regulatory Submissions, Health Authority Interactions, Structured Content Planning (SCP), and related regulatory business processes.
Establish and maintain enterprise regulatory data standards, governance processes, stewardship models, metadata, business rules, and data quality practices supporting global regulatory operations.
Lead Moderna’s business ownership for IDMP, xEVMPD, and future global structured regulatory data initiatives, ensuring alignment with evolving Health Authority requirements.
Define and execute Moderna’s strategy for AI-enabled regulatory data management, leveraging artificial intelligence, Vibe Coding, automation, and advanced analytics to improve regulatory intelligence, operational efficiency, and business decision-making.
Develop and maintain enterprise reporting, dashboards, and analytics utilizing Veeva Vault RIM, Tableau, and future business intelligence platforms.
Define the business strategy supporting enterprise integrations, including AdPromo, Change Control, Enterprise Data, and Data Lake capabilities.
Establish Moderna’s Regulatory Data Migration capability, developing repeatable methodologies, governance models, business rules, and reusable migration assets supporting future regulatory technology implementations.
Partner with Digital to define business requirements, prioritize enhancements, evaluate new Veeva Vault RIM capabilities, and deliver continuous improvements across assigned business capabilities.
Lead business readiness activities supporting Veeva Vault RIM releases, including business impact assessments, testing coordination, user adoption, communications, and training.
Ensure regulatory data security, object security, access governance, and compliance requirements are maintained while promoting data integrity and inspection readiness.
Serve as the enterprise subject matter expert for Regulatory Data Management, partnering across Regulatory Affairs, Regulatory Operations, CMC, Labeling, Quality, Enterprise Data, and Digital to deliver scalable, compliant, and innovative business solutions.
Influence enterprise regulatory data strategy while balancing strategic leadership with hands-on execution and continuous improvement.
May manage direct reports, contractors, consultants, and external service providers.
Bachelor’s degree with 12+ years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Information Management, Data Management, Computer Science, or related disciplines.
Master’s degree with 10+ years of relevant experience.
Extensive experience with Veeva Vault RIM is required, including business ownership of regulatory data objects, workflows, reporting, object security, integrations, and release management.
Demonstrated experience serving as a Business Capability Owner, Product Owner, Functional Lead, or equivalent leadership role supporting Veeva Vault RIM capabilities.
Strong understanding of global regulatory submissions, registrations, regulatory master data, applications, and Health Authority interactions.
Experience supporting global structured regulatory data standards including IDMP, xEVMPD, or similar regulatory initiatives.
Demonstrated experience leading enterprise governance programs, technology implementations, business transformation initiatives, or regulatory data migration projects.
Experience partnering with Digital organizations to develop business requirements and deliver enterprise technology capabilities.
Deep understanding of Regulatory Information Management and enterprise regulatory data governance.
Advanced knowledge of Veeva Vault RIM data architecture, object model, reporting capabilities, metadata, security, and release management.
Experience with Veeva Vault RIM Applications, Registrations, Submissions, Products, Organizations, and Health Authority data objects.
Experience utilizing Tableau, Veeva reporting, or comparable business intelligence platforms to develop enterprise dashboards and analytics.
Experience leading enterprise data migration initiatives and regulatory technology implementations.
Knowledge of enterprise integrations, APIs, middleware, and Data Lake architectures.
Experience leveraging artificial intelligence, automation, advanced analytics, or Vibe Coding to improve regulatory business processes.
Excellent communication, stakeholder management, organizational change management, and leadership skills.
Ability to influence cross-functional teams while balancing strategic leadership with hands-on execution.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Our Working Model
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations
We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
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